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To Evaluate the PK, PD, Safety and Drug Tolerance of JW0302 in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics After Oral Administration of JW0302 to C2206 in Healthy Adult Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05784155
Enrollment
44
Registered
2023-03-24
Start date
2023-03-10
Completion date
2023-06-26
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Interventions

DRUGTest Drug(JW0302) or Reference Drug(C2206)

Test Drug: single administration of JW0302 Reference Drug: single administration of C2206 Tablet, Oral, QD for 1 Days, Washout period is more than 14 days after administration

Sponsors

JW Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Intervention model description

A randomized, open, single-dose, 2x2 crossover-design clinical trial

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers

Exclusion criteria

* Subjects does not meet the Inclusion Criteria

Design outcomes

Primary

MeasureTime frameDescription
AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)up to 24 hoursEvaluation PK for JW0302 and C2206 after multiple dose
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th doseBaseline versus Multiple dose during 7 daysEvaluation PD for ambulatory 24hr pH monitor

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026